Nail Patch with Solubilizer for Targeted Drug Delivery

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Solution Overview

Problem

Conventional nail patches for treating tinea unguium have high drug permeability into the skin, leading to side effects like liver damage, and insufficient drug permeability into the nails, limiting their therapeutic effectiveness.

Innovation Solution

A nail patch comprising a backing layer and a pressure-sensitive adhesive layer with terbinafine, sodium acetate, and sorbitan monolaurate as a solubilizer, which enhances drug permeability into the nails while minimizing skin permeability, allowing for high-dose, continuous drug delivery.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Quantity of substance

If conventional nail patches are used to deliver terbinafine into nails, then drug permeability into nails is improved, but drug permeability into skin increases causing side effects like liver damage

Engineering Contradiction:
Improvedrug permeability into nailsVSAvoidside effects from skin absorption
Core Design Contradiction:
Quantity of substanceVSObject-affected harmful factors

Solution Approach 1:

The patent applies local quality by creating a pressure-sensitive adhesive layer with specific local properties (pH 3-6 and containing solubilizer) that selectively enhances drug permeability into nails while minimizing skin absorption. The adhesive layer is formulated to interact specifically with nail structure rather than skin, achieving location-specific drug delivery.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The patent changes critical parameters of the pressure-sensitive adhesive layer including pH (3-6), water content (5-20%), and composition (containing solubilizer like polyethylene glycol or propylene glycol). These parameter changes enable the adhesive to selectively permeate drug into nails while reducing skin absorption, resolving the contradiction between effective nail penetration and minimizing systemic side effects.

Inventive Principle:
Principle #35Parameter changes

2Object-affected harmful factors

If external preparations like liquid medicines are used, then side effects are reduced, but drug permeability into nails is insufficient

Engineering Contradiction:
Improveside effects reductionVSAvoiddrug permeability into nails
Core Design Contradiction:
Object-affected harmful factorsVSQuantity of substance

Solution Approach 1:

The patent transforms the liquid medicine approach into a pressure-sensitive adhesive formulation with specific parameters (pH 3-6, water content 5-20%, containing solubilizer). This parameter transformation enables the preparation to achieve both low side effects (by avoiding systemic absorption) and high drug permeability into nails (through controlled release and enhanced penetration).

Inventive Principle:
Principle #35Parameter changes

Solution Approach 2:

The pressure-sensitive adhesive layer provides continuous drug release and prolonged contact with the nail surface, ensuring sufficient cumulative drug permeation into nails. This continuous action overcomes the limitation of liquid medicines that are difficult to administer continuously, while maintaining low systemic exposure and side effects.

Inventive Principle:
Principle #20Continuity of useful action

3Quantity of substance

If nail patches with high drug content are used to achieve sufficient therapeutic effect, then drug permeability into nails is improved, but drug permeability into skin increases causing systemic absorption

Engineering Contradiction:
Improveamount of drug delivered to nailsVSAvoidsystemic absorption and liver damage
Core Design Contradiction:
Quantity of substanceVSObject-generated harmful factors

Solution Approach 1:

The patent uses local quality by formulating the pressure-sensitive adhesive layer with pH 3-6 and solubilizer specifically to target nail tissue. This local formulation ensures that high drug content is selectively delivered to nails rather than being absorbed into systemic circulation, achieving high therapeutic effect without proportional increase in systemic side effects.

Inventive Principle:
Principle #3Local quality

Solution Approach 2:

The pressure-sensitive adhesive layer acts as an intermediary between the drug and the nail/skin tissues. It controls drug release and permeation selectively, allowing high drug content to be delivered to nails while preventing excessive skin absorption. The adhesive mediates the interaction between drug and tissues, resolving the contradiction between high dose delivery and low systemic exposure.

Inventive Principle:
Principle #24Intermediary (Mediator)

Applied Scientific Principles

This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.

Function Achieved in This Case

The nail patch achieves improved therapeutic effects for tinea unguium with reduced side effects by ensuring sufficient drug delivery to the nails while preventing systemic absorption, thus minimizing liver damage.

Implementation Method 1

sorbitan monolaurate as a solubilizer, which enhances drug permeability into the nails

Methodology Applied
Scientific EffectPermeation: Permeation

Data Source

PatentUS8771726B2Nail patch
Publication Date: 2014.07.08 HISAMITSU PHARM CO INC

AI summary

The present subject matter provides a nail patch comprising a backing layer and a pressure-sensitive adhesive layer disposed on at least one side of the backing layer, wherein the pressure-sensitive adhesive layer comprises a pressure-sensitive adhesive base, terbinafine and/or a pharmacologically acceptable salt thereof, and sodium acetate and/or sorbitan monolaurate as a solubilizer.